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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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Cancer Immunotherapies: EMA to Hold November Workshop

The European Medicines Agency (EMA) on Tuesday announced that its Committee for Advanced Therapies (CAT) is organizing a workshop on 15 and 16 November 2016 to discuss the scientific and regulatory challenges of immunotherapy medicines based on genetically modified T-cells (white blood cells that fight off viruses and bacteria).

As EMA explains, “Immunotherapy is a type of cancer treatment that mobilizes the body's own defense mechanisms to fight cancer. Immunotherapy medicines have significantly changed the therapeutic landscape, particularly for the treatment of patients with certain cancers, such as lung cancer or melanoma.”

The subject of the workshop is a specific type of immunotherapy that has received a lot of attention and investment this year and focuses on genetically engineering T cells from a patient’s blood in a laboratory in order to allow them to recognize cancer cells through specific receptor proteins, with the hopes of using the modified T-cells to identify and destroy cancer cells.

Despite some early signs of success in some trials, EMA notes that “there are still many scientific and regulatory challenges to be overcome before these innovative products can be brought to the market for the benefit of patients.”

The workshop aims to facilitate dialogue between the CAT and drug developers from industry and academia on:

Stanley Frankel, head of immuno-oncology clinical research and development at Celgene, will present at the workshop on “Taking CARs/TCRs [chimeric antigen receptor (CAR) T-cells] from first-in-man trials to marketing authorisation – the view from a pharmaceutical developer.”